Analgesic implant device and system

ABSTRACT

Techniques associated with an implant system for imparting vibratory massage to tissue within a body is disclosed. Methods include placing an implant device near a surface of a colon, the implant device configured to produce and communicate a vibration to colon tissue, the implant device including a case forming a portion of an exterior of the implant device and defining an interior of the implant device, a vibration generator mounted on the case to vibrate the implant device, and a tissue engaging structure located on the exterior surface of the case to engage the colon tissue, securing the implant device to the colon, and activating the vibration generator of the implant device to cause the implant device to vibrate against the colon, wherein the vibration stimulates a nerve to induce a bowel movement.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/326,649, filed Dec. 2, 2008, now U.S. Pat. No. 8,512,264 which is acontinuation-in-part of U.S. patent application Ser. No. 11/784,376,filed Apr. 6, 2007, now U.S. Pat. No. 8,512,264 and is related toco-pending U.S. patent application Ser. No. 13/586,719, filed Aug. 15,2012, entitled “Analgesic Implant Device and System,” U.S. patentapplication Ser. No. 13/586,742, filed Aug. 15, 2012, entitled“Analgesic Implant Device and System,” U.S. patent application Ser. No.13/586,807, filed Aug. 15, 2012, entitled “Analgesic Implant Device andSystem,” all of which are incorporated by reference herein in theirentirety for all purposes.

FIELD

The present invention relates to pain relief, and more particularly toan analgesic implant device and system.

BACKGROUND

The analgesic effects of kinetic remedies such as vibratory massage arewell known in the medical field. Vibratory stimulation of muscle andother bodily tissue has been a proven medical therapy for many years.One problem facing many people suffering from pain is that a kineticremedy can rarely be readily administered at the first signs ofdiscomfort. Many of the causes of pain can be significantly relieved orreduced if treatment is administered during the early onset of pain.Further, using known equipment and techniques it can be difficult toapply vibratory stimulation to the affected area for long periods oftime, or at least as long as the pain may persist, and thus may onlyprovide a temporary relief.

Another problem facing pain sufferers is that the source of the pain maydevelop in an area of the body that is not readily or effectivelyaccessible by known vibratory massage devices. In many cases the sourceof the symptom is buried too deep within the body for an externalvibratory massage device to have any significant effect withoutirritating the intervening tissue. In other cases the source of thesymptom may be too close to other sensitive tissue that would beadversely affected by an external vibratory stimulus strong enough to beeffective on the tissue that is the source of the pain. In yet othercases the source of the pain is isolated from the effects of an externalkinetic remedy by bone or other tissue that may dampen or otherwiseattenuate the vibratory effect.

For example, some have proposed instruments employed for the removal ofintervertebral implants that use ultrasonic vibrations to loosen anddislodge the prosthesis from the adjoining bone. This instrument is usedduring a surgical process, and is not believed to be suitable forapplying useful vibrational massage to tissue for any length of time.

Others have proposed devices that employ ultrasonic vibrational energyin place of electrical stimulus for cardiac pacing, cardioversion, anddefibrillation in response to detected arrhythmia. Such devices do notappear to be designed to provide vibrations with amplitude that iscapable of providing pain relief. Further, these devices apply thevibrations to the heart or lungs, and some of the device even appear toemploy vibrational elements located inside one of the ventricles of theheart, and thus is not suggestive of something that could provide painrelief.

Still others have proposed device that apply vibrations to the exteriorof the body for various purposes. For example, systems have been devisedfor translating feelings or sensations from a prosthetic limb to theresidual limb using acoustic vibrations, and is not designed or intendedfor therapeutic pain relief.

Yet others have proposed devices that are implanted in the body but areonly caused to vibrate by stimulus applied from outside the body, suchas when an acoustic transducer located outside of the body focusesenergy on the implanted device. Thus, the implanted device is not ableto generate vibrations by itself without the external stimulus beingapplied.

Further, devices have been proposed for implantation for the purpose ofhearing assistance, audiological support, or replacement and testing.Although many of these devices include a vibratory element, the purposeof the vibratory generation is to pass on acoustic stimulation tosensory organs and is not believed to be suitable for vibratory massage.

Therefore what is needed is a device that has the ability to administervibratory stimulus to the source of pain in a direct manner so as toadminister the vibratory massage in a targeted manner to the tissue of apatient with the least amount of collateral effect, and has the abilityto apply the vibratory massage at the earliest signs of the occurrenceof the pain.

SUMMARY

To meet these needs, the present invention generally provides amedically implanted device that can be positioned proximate to thesource of pain and is capable of administering a vibratory massage usinga relatively low amount of force necessary to remedy the pain withoutadversely affecting the surrounding tissue.

In one aspect of the invention, an analgesic implant system is disclosedfor imparting vibratory massage to tissue of a patient from within thebody of the patient.

The system comprises an implant device configured to produce andcommunicate a vibration to body tissue located adjacent to the implantdevice. The implant device may include a case forming at least a portionof an exterior of the implant device and defining an interior of theimplant device, and a vibration generator configured to vibrate the atleast a portion of the exterior of the implant device. The device mayfurther include a power supply configured to supply power to thevibration generator and a switch configured to selectively permit powerfrom the power supply to be supplied to the vibration generator. Theimplant device may still further include a power receiver configured toreceive electrical energy from a location external to the body of thepatient when the implant device is implanted within the body of thepatient and a signal receiver configured to receive signals from alocation external to the body of the patient when the receiver islocated in the body of the patient, with the signal receiver being incommunication with the switch to actuate the switch.

In another aspect of the invention, a method of imparting vibratorymassage to tissue of a body of a patient is disclosed, and may compriseproviding an implant device, identifying tissue within the body of thepatient as a source of discomfort, implanting the implant device withinthe body of the patient, and causing vibration of the implant devicewithin the body of the patient to thereby vibrate the identified tissue.

In yet another aspect of the invention, an analgesic implant system isdisclosed for imparting vibratory massage to tissue of a patient fromwithin the body of the patient. The system comprises an implant deviceconfigured to produce and communicate a vibration to bone tissue of thebody of the patient. The implant device includes a case forming at leasta portion of an exterior of the implant device and defining an interiorof the implant device, with the case having an exterior surface havingan elongated shape with a longitudinal axis and a first end and a secondend. The implant device further includes a vibration generator mountedon the case and configured to vibrate the at least a portion of theexterior of the implant device. The implant device also includes atissue engaging structure located on the exterior surface of the caseand configured to secure the case on the bone tissue of the body of thepatient.

In still another aspect of the invention, a method of suppressingappetite in a patient is disclosed. The method comprises providing animplant device configured to produce and communicate a vibration totissue of the body of the patient, and the implant device includes acase forming at least a portion of an exterior of the implant device anddefining an interior of the implant device, a vibration generatormounted on the case and configured to vibrate the at least a portion ofthe exterior of the implant device, and a tissue engaging structurelocated on the exterior surface of the case and configured to secure thecase on the tissue of the body of the patient. The method furthercomprises securing the implant device to an exterior surface of thestomach of the patient, and activating the vibration generator of theimplant device to cause the implant device to vibrate against theexterior surface of the stomach.

In yet still another aspect of the invention, a method of inducingurination by a patient is disclosed. The method comprises providing animplant device configured to produce and communicate a vibration totissue of the body of the patient, and the implant device includes acase forming at least a portion of an exterior of the implant device anddefining an interior of the implant device, a vibration generatormounted on the case and configured to vibrate the at least a portion ofthe exterior of the implant device, and a tissue engaging structurelocated on the exterior surface of the case and configured to secure thecase on the tissue of the body of the patient. The method furtherincludes securing the implant device to an exterior surface of thebladder of the patient, and activating the vibration generator of theimplant device to cause the implant device to vibrate against theexterior surface of the bladder.

In another aspect of the invention, a method of inducing a bowelmovement by a patient is disclosed. The method comprises providing animplant device configured to produce and communicate a vibration totissue of the body of the patient, with the implant device including acase forming at least a portion of an exterior of the implant device anddefining an interior of the implant device, a vibration generatormounted on the case and configured to vibrate the at least a portion ofthe exterior of the implant device, and a tissue engaging structurelocated on the exterior surface of the case and configured to secure thecase on the tissue of the body of the patient. The method furtherincludes securing the implant device to an exterior surface of the colonof the patient, and activating the vibration generator of the implantdevice to cause the implant device to vibrate against the exteriorsurface of the colon.

A significant benefit provided by the present invention is thatvibratory massage may be applied in a more direct manner to internaltissue that may not normally be effectively treated by vibration massageapplied to the exterior of the body of the patent. Also, the vibrationmay be applied without significantly limiting the activities of thepatient while the massage is being applied. Further, the massage may beapplied more quickly when a pain condition arises, and may be continuedas long as the pain condition persists, again without the massageotherwise limiting the activities of the patient.

Further advantages of the invention, along with the various features ofnovelty which characterize the invention, are pointed out withparticularity in the claims annexed to and forming a part of thisdisclosure. For a better understanding of the invention, its operatingadvantages and the specific objects attained by its uses, referenceshould be made to the accompanying drawings and descriptive manner inwhich there are illustrated embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments or examples of the invention are disclosed in thefollowing detailed description and the accompanying drawings:

FIG. 1 is a schematic side view of a patient illustrating various partsof the system in accordance with the present invention;

FIG. 2 is a schematic block diagram of an embodiment of the presentinvention illustrating the functional components and theirrelationships;

FIG. 3 is a schematic block diagram of another embodiment of the presentinvention that includes a charging circuit;

FIG. 4 is a schematic block diagram of yet another embodiment of thepresent invention that includes a microprocessor;

FIG. 5 is a schematic top perspective view of an implant device inaccordance with an embodiment of the present invention;

FIG. 6 is a schematic bottom perspective view of the implant device ofFIG. 5 in accordance with an embodiment of the present invention;

FIG. 7 is a schematic exploded view of the implant device of FIG. 5 inaccordance with an embodiment of the present invention;

FIG. 8 is a schematic perspective view of another implant device inaccordance with an embodiment of the present invention;

FIG. 9 is a schematic side cross sectional view of the implant device of

FIG. 8 in accordance with an embodiment of the present invention;

FIG. 10 is a schematic top cross sectional view of the implant device ofFIG. 8 in accordance with an embodiment of the present invention;

FIG. 11 is a schematic perspective view of the implant device of FIG. 8utilizing a mesh mounting method;

FIG. 12 is a schematic top perspective view of yet another implantdevice according to an embodiment of the present invention;

FIG. 13 is a schematic bottom perspective view of the implant device ofFIG. 12 according to an embodiment of the present invention;

FIG. 14 is a schematic exploded view of the implant device of FIG. 12 inaccordance to an embodiment of the present invention;

FIG. 15 is a schematic top perspective view of a different embodiment ofan implant device according to an embodiment of the present invention;

FIG. 16 is a schematic cross sectional view of the implant device ofFIG. 15 according to an embodiment of the present invention;

FIG. 17 is a schematic exploded view of the implant device of FIG. 15 inaccordance to an embodiment of the present invention;

FIG. 18 is a schematic exploded perspective view of yet a differentimplant device according to an embodiment of the present invention;

FIG. 19 is a schematic top view of the implant device of FIG. 18 withaccompanying mounting elements in accordance with an embodiment of thepresent invention;

FIG. 20 is a schematic side cross sectional view of the implant deviceof FIG. 18 according to an embodiment of the present invention;

FIG. 21 is a schematic anatomically exploded view of a leg illustratingvarious methods of mounting various implant devices in accordance withvarious embodiments of the present invention;

FIG. 22 is a schematic cross sectional view of the implant device 12B ofFIG. 21 utilizing a screw method of mounting in accordance with anembodiment of the present invention;

FIG. 23 is a schematic cross sectional view of the implant device 12C ofFIG. 21 utilizing a back plate mounting method according to anembodiment of the present invention;

FIG. 24 is a schematic cross sectional view of the implant device 12D ofFIG. 21 utilizing a band method mounting method in accordance with anembodiment of the present invention;

FIG. 25 is a schematic anatomically exploded view of a leg illustratingvarious methods of mounting multiple implant devices according to one ormore embodiments of the present invention;

FIG. 26 is a schematic perspective view of an alternative implant deviceaccording to an embodiment of the present invention;

FIG. 27 is a schematic sectional view of a bearing member of the implantdevice of FIG. 26 in accordance with an embodiment of the presentinvention;

FIG. 28 is a schematic side view of a pair of spinous processes locatedon adjacent vertebrae of the spine, particularly illustratingpreparation of the processes for mounting the implant device of FIG. 26;

FIG. 29 is a schematic axial view of adjacent spinous processes with anembodiment of an implant device similar to that shown in FIG. 26 mountedon the processes;

FIG. 30 is another schematic axial view of adjacent spinous processesfrom a vantage point opposite of the axial view of FIG. 29 with theimplant device of FIG. 26 mounted thereon;

FIG. 31 is a schematic posterior view of adjacent spinous processes withthe implant device of FIG. 26 mounted thereon;

FIG. 32 is a schematic sectional view of adjacent spinous processes withthe implant device of FIG. 26 mounted thereon, taken along line 31 ofFIG. 31;

FIG. 33 is a schematic perspective view of a tool suitable for engagingthe tool engaging structure of the bearing structure of FIG. 27;

FIG. 34 is a schematic top view of another alternative implant device inaccordance with an embodiment of the present invention;

FIG. 35 is a schematic sectional view of the implant device of FIG. 34taken along line 35 of FIG. 34 with components internal to the casebeing omitted for clarity;

FIG. 36 is a schematic illustration of the implant device of FIG. 34shown surgically secured to the wall of the stomach of a patient inaccordance with an embodiment of the present invention;

FIG. 37 is a schematic sectional view of the implant device of FIG. 34taken along line 37 of FIG. 36;

FIG. 38 is a schematic illustration of still another alternativeembodiment of an implant device secured to the bladder of a patient inaccordance with an embodiment of the present invention;

FIG. 39 is a schematic illustration of yet another alternative implantdevice device secured to the colon of a patient in accordance with anembodiment of the present invention;

FIG. 40 is a schematic illustration of a different alternative implantdevice positioned in the pelvic region of a female in accordance with anembodiment of the present invention;

FIG. 41A is a schematic illustration of yet a different alternativeimplant device positioned in a flaccid penis, with the implant devicebeing shown in broken lines, in accordance with an embodiment of thepresent invention; and

FIG. 41B is a schematic illustration of still a different alternativeimplant device positioned in an erect penis, with the implant devicebeing shown in broken lines, in accordance with an embodiment of thepresent invention.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in detail sufficient toenable those skilled in the art to practice the invention, and it is tobe understood that other embodiments may be utilized and thatstructural, logical and mechanical changes may be made without departingfrom the spirit and scope of the present invention. The followingdetailed description is, therefore, not to be taken in a limiting sense,and the scope of the present invention is defined by the appendedclaims.

FIG. 1 depicts one embodiment of the apparatus of the analgesic implantsystem (10) which includes an implant device (12), a charging system(14) and a remote control device (16). As shown in greater detail inFIG. 2, the charging system (14) may include an inductive transmittingcoil (88) that may be positioned in relatively close proximity to thereceiving coil (86) within the implant device (12) to permit rechargingof the internal power supply (78) without requiring a wired connectiontherebetween.

Turning back to FIG. 1, the transmitting coil (88) may be put intoelectrical communication with a power source (3), which is illustratedas a common electrical outlet but is not so limited. FIG. 1 shows thetransmitting coil (88) of the charging system (14) illustrativelymounted to a piece of furniture (2), such as the chair depicted, but theinvention is not so limited, and other convenient locations such as themattress pad of a bed, a car seat in a vehicle or even clothing arewithin the scope of the invention. The transmitting coil (88) may beattached to the outer surface of the chair but it is anticipated thatthe charging system (14) may be integrated into a piece of furniture (2)so that its presence is less obvious.

To increase the convenience of use of such an implanted device over aprolonged period of time, the implant device (12) may be self-containedwith all critical elements contained within the case (20) and may alsobe hermetically sealed. The wireless remote control device (16)facilitates these characteristics. As a self contained implanted devicemay have a limited amount of power to operate the implant device, awireless system for recharging the device is useful so that the internalpower supply (78) may be fully integrated into the device (12), and mayeven be fully contained in, the case (20). The propensity of a vibratingdevice to shift or even migrate within a subject's body would stipulatethat the implant device be mounted to the region to which its functionis to be applied. Therefore the device would require various securingmethods suitable to the type of tissue within the device's proximity.

The remote control device (16) may be any device that the patient (1) isable to operate and utilize to send wireless signals that areinterpretable by the implant device (12) to regulate the function of theimplant device (12). The medium of wireless communication may includeany frequencies of the electro-magnetic spectrum including radio waves,microwaves, magnetic impulses and the like. The remote control device(16) is illustrated in FIG. 1 in the hand of the patient (1), and may beconfigured similar to other handheld remote control devices (16) used tocontrol televisions, media devices, car doors, computers, and garagedoors, but the invention is not so limited. It is anticipated that theremote control device (16) may be in the form of a cellular phone incommunication with a larger communications network (18) (see FIG. 4),and may send signals to the implant device (12) via a central broadcastlocation. Optionally, the remote control device (16) may be coupled orcombined with the transmitting coil (88) to send control input or datato the implant device (12) via information encoded within the energytransmitted by the transmitting coil. In this example the user interfacemay be coupled to the charging system (14) or the furniture (2) whereinthe charging system (14) resides.

The implant device (12) is shown in FIG. 1 surgically implanted into theback of the patient (1). The implant device (12) may be positioned inalmost any location within the patient (1), such as locations among thevarious organs and tissues of the patient (1). It should be recognizedthat positioning the implant device (12) in different locations mayaffect the appropriate placement of the transmitting coil (88) of thecharging system (14) so that the transmitting coil (88) is locatedwithin a functional proximity to the receiving coil (86) of the implantdevice (12).

FIG. 2 illustrates a relatively simple embodiment of the operationalstructure and interaction of the functional elements of the analgesicimplant system (10). The power source (3) provides electricity to thetransmitting coil (88) that inductively transfers power to the receivingcoil (86) located within the case (20) of the implant device (12). Thistransference of power is represented by the wavy lines between thetransmitting coil (88) and the receiving coil (86). The power from thereceiving coil (86) is sent to the internal power supply (78) andstored, such as by a rechargeable battery, for later use. Alternatelythe power could be passed directly to the vibration generator (62) as itis being received by the receiving coil (86). The remote control device(16) may send a signal depicted as radiating curved lines, upon theactuation of a user interface via a transmitter (94) to the receiver(92) that may be located within the case (20) of the implant device(12). The user interface may comprise a button, lever switch, knob,touch pad, touch screen, voice activation system, and the like. Thereceiver (92) may communicate the signal to a switch (90) that controlsthe flow of power to the vibration generator (62). The vibrationgenerator (62) may be rigidly attached to the case (20) to cause thecase (20) of the implant device (12) to vibrate thus producingmechanical waves to massage the tissue in contact with the case (20) ofthe implant device (12). The vibration generator (62) may employ anumber of different means to produce the vibrations, for example; anelectrical motor (64) coupled to a flywheel (70) with an eccentric mass,a piezoelectric vibrator (72), a solenoid (76), a magnetic oscillator(74) and the like. Other methods of producing a vibration are well knownto those skilled in the art.

FIG. 3 depicts a similar system to the embodiment illustrated in FIG. 2with the inclusion of a charging circuit (84). The charging circuit (84)represents one of many types of circuitry that may benefit the functionof the implant device (12). A charging circuit (84) may be employedwithin the implant device (12) to control proper charging and/ordischarging of the internal power supply (78), to maintain the life ofthe internal power supply (78), reduce the possibility or lessen theeffect of hydrogen evolution in a rechargeable battery (80) or tomonitor and report the status and/or condition of the internal powersupply (78), for example, to the patient (1).

FIG. 4 depicts the analgesic implant system (10) with additionalelements to further expand the functionality of the system (10). Theimplant device (12) in FIG. 4 includes a micro processor (96) that mayprovide a plurality of functions through the application of logicalprocesses. Physically the switch (90) may be integrated into themicroprocessor (96) but optionally the switch (90) may remain separate.Likewise the charging circuit (84) may be integrated into the microprocessor (96) or may be a physically separate element.

The functions of a micro processor (96) within the implant device (12)may be further expanded if the data communicated between the implantdevice (12) and the remote control (16) is transmitted over acommunications network (18) by, for example, for sharing with otherentities, such as other people or systems so it is therefore anticipatedthat the remote control device (16) may be.

In general, the vibration generator (62) causes at least a portion ofthe case to vibrate with an amplitude sufficient to affect and transmitvibration to adjacent tissue, and at least one, and maybe more than one,frequency that is suitable for providing a massage to the adjacenttissue. In virtually all embodiments of the invention, the frequency orfrequencies employed are sub-ultrasonic, and may be in the range ofthose frequencies below 20 kHz. Other embodiments may employ frequenciesbelow 10 kHz. It is believed that the most useful frequencies arebetween approximately 1 kHz and 8 kHz, and frequencies within the rangeof approximately 1400 Hz and 7200 Hz are even more effective, with someof the most effective frequencies occurring between approximately 3240Hz and 3250 Hz. Of course, the frequency or frequencies employed maydepend upon the tissue to be treated, and the type of treatment to beadministered.

If an electrical motor (64) is employed as a vibration generator (62)the specific type of motor (64) used may vary depending on therequirements of the implant device (12). Structurally miniatureelectrical motors (64) are known to those skilled in the art, includingdisc motor (68) configurations as well as cylindrical motor (66)configurations to facilitate the desired location of the implant device(12) and the requisite effect desired to alleviate or eliminate pain inthe patient (1). The operational speed of the motor (64) may be used tocontrol the frequency of the vibrations generated. The frequency of thevibrations employed may be specific to the type of tissue to be affectedor optionally the frequency of the vibrations may be selected for thetype of the tissue that is desired to remain unaffected by thevibrations during administration of a vibratory massage remedy. Thefrequency of the vibrations employed may also be affected by the sourceor specific symptoms of the pain. In some embodiments, a variable speedmotor (64) permits the speed of the motor (64) may be controlled to varythe frequency of the massage vibrations produced by the device. In someembodiments, the speed of the motor (64) may be controlled via theswitch (90) by controlling the amount of power flowing to the motor(64). Optionally, a microprocessor (96) may control the switch (90) toobtain the frequency or frequencies desired.

In embodiments utilizing an electrical motor (64) as the vibrationgenerator (62), the weight of the eccentrically-mounted mass and thedegree of eccentricity from the axis of rotation affects the amplitudeof each vibration. The amplitude of the vibrations may be selected basedupon the type of tissue to be affected. For example, bone tissue (6) mayrequire a higher degree of amplitude than soft muscle tissue (4) toachieve the desired effect. The amplitude of the vibration may also beselected based upon the proximity of the implant device (12) to thetissue that is the target of the vibratory massage. For example, if thetissue that is the target of the vibratory massage is in direct contactwith the implant device (12), the amplitude required may be lower thanif the targeted tissue is relatively large in size or if the vibrationsneed to be communicated through intervening tissue to reach the targetedtissue. Also, the source or specific symptoms of the pain may be mosteffectively remedied by a vibration of specific amplitude. The magnitudeof the mass of a flywheel (70) and/or the degree of eccentricity of theflywheel may dictate the amplitude of the vibration produced by thevibration generator (62). Predefined levels of amplitude may beestablished by the mechanical structural design of the flywheel (70)during manufacture. Optionally, the magnitude of the mass and/or thedegree of the eccentricity (controlled by the placement of the mass onthe flywheel (70)) may be varied mechanically. There are a number ofways of mechanically varying the positioning of the mass on the flywheel(70). One such illustrative example is shown in FIG. 18 in which a setof flywheels (70) may engage the shaft or axle of a motor (64) as themotor (64) shifts positions. By varying the collective number and/orposition of the flywheels (70), the sum of the eccentric mass can bevaried. Each flywheel (70) includes a specific mass that is positionedeccentrically with respect to the axis of the flywheel (70). Through theuse of a direct current stepper motor (64) the various weighted sectionscan be combined in various configurations that change the center of massto thereby vary the eccentricity. For example, if two flywheel (70)discs are engaged by the motor (64) in a manner such that the masses areopposed at an angle of 180° to each other, the mass of the combinedflywheel (70) would be centered upon the axis and the vibrationgenerator (62) would not produce vibrations as there would be noeccentricity. If the two flywheel (70) discs are coupled to each otheron the axle with the masses positioned at a 90° angle with respect toeach other, the collective center of mass would be located along an axisoriented at an angle between the masses at a smaller diameter from theaxis than the actual placement of the masses to produce a medialvibratory amplitude. If the two flywheel (70) discs where coupled toeach other on the axle with both masses oriented at the same angle tothe axis of the axle, the center of mass would be at the farthest radialdistance from the axis of the axle to produce the greatest amount ofvibratory amplitude. Many other techniques for mechanically varying massand eccentricity are known to those skilled in the art.

If a piezoelectric vibrator (72) is employed as a vibration generator(62), a range of frequencies can be achieved electronically bycontrolling the polarization of the dipole crystal lattice within theceramic of the piezoelectric vibrator. Piezoelectric vibrators (72) arecommonly constructed in arrays or layers of individual piezoelectricceramic wafers, and by increasing or decreasing the number of individualwafers, layers or sections of an array that contribute to thepiezoelectric displacement of crystal dipoles, the amplitude of thevibration may be increased or decreased.

The frequency and amplitude of magnetic oscillators (74) and solenoids(76) may be controlled by managing the level and type of current to thedevices and/or by mechanically altering the displaced mass. In theexample of a solenoid (76), the amount of power supplied determines theacceleration of the core through the magnetic coil. Quick accelerationmay produce more amplitude and slower acceleration may produce lessamplitude. Also, increasing or decreasing the amount of weight attachedto the core may correspondingly increase or decrease the amplitude ofvibration. Techniques for controlling the frequency and amplitude ofvibration generating devices are well known to those skilled in the art.

FIG. 5 shows one embodiment of an implant device (12) of the invention.The exterior of the implant device (12) in this embodiment is generallydisc shaped, which may facilitate or enhance the function of the implantdevice with respect to the tissue to be treated (through, for example,contact). The exterior shape may also optimize the function of theimplant device (12) when used in certain locations within the patient(1). The shape of the case (20) of the device (12) is depicted as asimple disc, but the shape may include other contouring such as roundededges and angles on the exterior surface may be sculpted to conform orcorrespond to the tissue that the implant device (12) may be in contact.The shape of the case (20) may vary widely and may be a function of thesize and shape of the components housed in the interior (60), the mannerin which the device (12) is to be secured in the patient, the contouringthat provides the optimal effect on the targeted tissue, the location ofthe implant device (12) within the patient (1) conducive to desiredeffect, and the characteristics of the adjacent tissue.

The external elements of the implant device (12) include a case (20)that may be designed to form a hermetically sealed envelope that mayprovide a barrier between the internal elements within the interior (60)of the implant device (12) and the bodily tissue of the patient (1). Thecase (20) may be formed of a biocompatible material that would resistrejection by the body of the patient (1). Examples of such materials mayinclude, for example, biocompatible metals, biocompatible polymers,silicone, glass, rubber, carbon, crystal, and the like. The selectedmaterial or materials should be of sufficient rigidity and durability tofacilitate and preserve the function of the implant device (12). Thecase (20) may be formed of a combination of different materials to takeadvantage of structural and functional characteristics of the variousmaterials.

To effectively locate the implant device (12) in the body of the patient(1), and also to resist dislocation or migration of the device withinthe body, it may be desirable to attach, mount or otherwise anchor thedevice (12) to bodily tissue. To facilitate the mounting of the implantdevice (12), the case (20) of the device (12) may include a primarymounting structure that forms a mount (28). The primary mountingstructure or mount (28) as used herein is a feature or an extension ofthe exterior (22) of the case (20) that is generally integral to thecase (20). The purpose of the mount (28) is to anchor the implant device(12) to tissue within the body of the patient (1) that is either nearthe target of the vibratory massage, can transmit the vibratory massageto the target or is the actual target of the vibratory massage. Themount (28) may include various structures depending on the specificmanner of mounting. For example, the mount (28) structure may include aflange (30), an aperture (32), a clamp (56), a mesh (48), a groove (58),an engaging surface (24), a tine (26) and the like. A mount (28) can beattached directly to the bodily tissue of the patient (1), or the mount(28) may be employed with a secondary mounting structure, or mountingelement (98), that mounts or attaches to the mount (28). A mountingelement (98) as used herein is an element that is also employed to mountthe implant device (12) in the body of the patient but is generally notintegral to the case (20). Examples of mounting elements (98) that maybe employed include an engaging surface (24), a tine (26), a screw (36),an aperture (32), a bolt (38) a nut (40), a plate (42), a line (44), aloop (46), a mesh (48), a suture (50), a staple (52) a band (54), aclamp (56), a groove (58), a chain, a pin, an adhesive, a hook, a rod, awedge, a barb, an engaging thread, a brad, a nail, a rivet, a clip, abuckle, a hinge, a plug, a cap and the like. It is anticipated that whenmounting an implant device (12) within a patient (1) that the implantdevice (12) may lack a mount (28) and rely on mounting elements (98) forits means of mounting. For example, an implant device (12) without amount (28) may be placed on deep fascia (5) of a muscle and immobilizedby overlaying a section of mesh (48) on top of the implant (12) andsuturing the mesh (48) to the deep fascia (5). Similarly the implantdevice (12) without a mount (28) may be directly adhered to the deepfascia (5) or bone tissue (6) with biocompatible adhesives. Somelocations for the implant device (12) may not require any means formounting as the anatomical topography itself would deter or restrictmovement or migration of the implant device (12) from the desiredlocation. For example, if the implant device (12) is inserted into abone, the bone tissue (6) itself may adequately secure the implantdevice (12) in the performance of its function. The specific type ortypes of mount, the combination of mounts (28), and/or the mountingelements (98) may be peculiar to the requirements of the location of theimplant device (12) in the patient (1) and the desired effect for painreduction or elimination.

A structure such as the tine (26) may comprise many forms and materials.For example, the tine (26) may include a metal barb, a polymer spine, aceramic tooth, a crystalline spike and the like. A tine (26) may engagetissue to form a rigid attachment so that the vibratory waves producedby the implant device (12) may communicate through the attached tissue.The surface of the tine (26) may include an osteophillic treatment topromote bone tissue (6) growth on the surface of the tine (26) thuscreating a stronger connection between the tine (26) and the bone. Atine (26) may be utilized as a mount (28) forming a part of the exterior(22) of the case (20) or may be utilized as a mounting element (98)either alone or in combination with other mounting elements, such as,for example on the jaws of a clamp (56) or forming a non skid surface ofa band (54).

A flange (30) may encompass many shapes and may be composed of a varietyof materials, such as metal, plastic, ceramic, carbon laminate, and thelike. The mount (28) of an implant device (12) may include a flange (30)as part of the exterior (22) of the case (20). Similarly a flange (30)may be used alone, or form a constituent part of a structure includingother mounting elements (98).

An aperture (32) is generally a hole formed in an object so that asecond object can occupy the area of the hole. Often the relationbetween the two objects is to form a joint between or otherwise connectthe two objects. An aperture (32) may be a part of a mount (28) usedalone or in combination of other mounts (28) such as a flange (30), mesh(48), band (54), clamp (56) and the like. An aperture (32) may also be amounting element (98) used alone or in conjunction with other mountingelements as a part of a mounting system.

A line (44) may take many forms, such as, for example, a metal wire, afiber thread, a polymer filament, and/or a combination ofbraided/twisted or layered materials forming a tendon. Depending on theresilience of the materials employed, a line (44) may also provide abuffering function between the implant device (12) and the tissue towhich the line (44) is connected. The degree of rigidity, flexibilityand elasticity of the line (44) may determine if the line (44) is ableto communicate or absorb mechanical vibratory waves between thesupporting tissue and the mounting elements (98).

A loop (46) may form a closed or partly open curve within itself throughwhich another material may extend or be encompassed. The loop (46) maycomprise any material suitable to engage bodily tissue and/or othermounting elements (98). As a mount (28), the loop (46) may comprise theentirety of the implant device (12) and have the form of, for example, aring, a crescent or a hemispheric-shaped element to encompass orsurround in whole or in part some portion of body tissue. In otherforms, a limited portion of the exterior (22) of the case (20) of theimplant device may form a closed or partly open curve. The loop (46) mayalso be a mounting element (98) that is utilized singularly or inconjunction with other mounting elements (98) such as a flange (30),screw (36), bolt (38), nut (40), plate (42), line (44), mesh (46), band(54), clamp (56) and the like.

Mesh (48) may have many forms and comprise various materials. Forexample, the mesh (48) may comprise a sheet of metal material with aplurality of holes formed therein, or may also comprise a textilestructure of threads or a network of filaments. The mesh (48) may form amount (28) on the exterior (22) of the case (20) of an implant device(12). The mesh may also form a mounting element (98) that is utilized asa means for mounting the device (12) to tissue either alone or incombination with other mounting elements.

A band (54) is generally a strip of material used to bind one object toanother object or to confine, restrict or restrain an object withrespect to the other object. A band (54) may be constructed of a widevariety of materials and may form either an open or closed circle. Aband may include means to secure one end of the band to an opposite endof the band (such as, for example, a belt buckle on a belt, hook andloop fasteners on a bra, a master link on a bicycle chain, and thelike). A band (54) may be a mount (28) or a mounting element (98) asdefined herein in a means for mounting an implant device (12) within thebody of a patient (1).

A clamp (56) may include a pair of gripping surfaces that are biasedtowards one another in opposition to secure an object or objectspositioned in between the surfaces. A clamp (56) may be formed by theentirety of the implant device (12), possibly having sections of thedevice (12) each having one of the gripping surfaces, and the interior(60) may be divided among the sections with the components of theimplant device (12) located in each of the sections. Optionally, alimited portion of the case (20) may form either one or both grippingsurfaces and function as a mount (28). As a mount, the clamp may be usedalone or with other mounting elements (98). The clamp (56) may also beutilized as a mounting element (98) either singly or in combination withother mounting elements (98) in a means for mounting an implant device(12) within the body of a patient (1).

A groove (58) may be a channel or depression formed in the exterior (22)of the case (20) of an implant device (12) so that other mountingelements (98) may engage the groove (58) to mount the implant device(12), but it should be recognized that the invention is not so limited.A groove (58) in the exterior (22) of the case (20) may be utilized toengage bodily tissue such as an artery, a vein, a tendon, a ligament, abone, and that like as a means for mounting the implant device, eitheralone or in conjunction with other mounting elements (98), in the bodyof the patient (1).

A buffer (34) may function either as a mount (28) or a mounting element(98) that has the ability to provide a degree of dampening of thevibratory wave action produced by the implant device (12) before thewave action reaches the tissue to which the buffer is connected. Forexample, a line (44) may function as a buffer (34) element if thematerial forming the line exhibits elastic, resilient and/or flexiblecharacteristics that attenuate or prevent the communication of a portionof the vibratory wave action along its length. As another example, amesh (48) may function as a buffer (34) element if the structuralcomposition or its constituent material of the mesh (48) generallyinhibits the communication of the vibratory waves emanating from theimplant device (12) through the mesh. As yet another example, asillustrated in FIG. 5, each of the apertures (32) positioned in theflanges (30) includes a ring of flexible material that functions todampen the vibration produced by the implant device (12) from beingtransmitted to a mounting element (98) engaging the aperture (32).

One embodiment of a mount (28) on the exterior (22) of the case (20) isillustrated in FIG. 5. The mount (28) takes the form of a flange (30)that includes an aperture (32).

In FIG. 6, the embodiment of the implant device (12) includes anengaging surface (24). A section of the exterior (22) of the case (20)may be designed to engage a specific type of tissue within the body ofthe patient (1) so that the implant device (12) may be held in anoptimal position to administer the vibratory massage. In FIG. 6 theengaging surface (24) comprises a relatively flat surface with tines(26) designed to engage tissue (6) such as, for example, bone. Thisparticular structure may be suitable for mounting the implant device(12) on a relatively flat section of bone tissue (6) such as, forexample, the scapula, and the ileum of the pelvis, the sternum, a rib,the mandible or the other bones of the skull. Functionally, theembodiment illustrated in FIG. 6 may have the engaging surface (24)pressed against bone tissue (6) so that the tines (26) penetrate intothe bone tissue (6) to provide a suitable connection to transmitvibratory waves to not only the bone but also the bodily tissue thatcontacts the bone. The mount (28) takes the form of a flange (30) and anaperture (32) and may be anchored to the bone through the use of screws(36) that pass through the aperture (32) and may be screwed into thebone tissue (6). To prevent direct communication of vibration betweenthe case (20) and the anchoring screws (36), a vibration isolatingbuffer (34) may be placed between the aperture (32) and the screws (36).The use of the buffer (34) may prevent the vibration of the implantdevice (12) from vibrating the screws (36) loose from the bone tissue(6). It is anticipated that the tines (26) may include additionalfeatures to better fix the implant device (12) to the bone tissue (6).For example, the tines (26) may include an ectopic porous coat possiblyused in conjunction with a morphogenic protein, or a hydroxyl apatitecoating to form an osteophillic surface so that bone tissue (6) wouldmore thoroughly engage with the engaging surface (24) on the exterior(22) of the case (20).

FIG. 7 illustrates constituent elements located in the interior (60) ofthe implant device (12) of the embodiment exhibited in FIGS. 5 and 6.The exploded view reveals that the individual elements may be layeredwithin the disc shaped case (20). One layer within the disc shaped case(20) may be the receiving coil (86) which may be comprised of a spiralof fine wire designed to receive power in the form of electromagneticinduction from a transmitting coil (88). Positioned in the center of thereceiving coil (86) may be the receiver (92) and the switch (90).Another layer may include the vibration generator (62), which maycomprise a motor (64) and a flywheel (70) having an eccentric mass. Themotor (64) in this embodiment is a disc motor (68) with the large massportion of the eccentric flywheel (70) occupying a radius substantiallycoextensive with the disc motor (68). Another layer may include thepower supply (78) such as a battery (80), and illustratively a buttoncell battery (80). It will be appreciated that the positioning or orderof the various layers may be different within the implant device (12)depending on various factors such as the specific effect desired,optimization of the components, and manufacturing considerations.

Another embodiment of the implant device (12), illustrated in FIG. 8,may be generally flat but not disc shaped. Like the embodimentpreviously described, the exterior (22) of the case (20) may includemounts (28) in the form of flanges (30) with apertures (32). The crosssection of this embodiment illustrated in FIG. 9 shows that the interior(60) components are not layered as in the previous embodiment but may bepositioned within the interior (60) based on the space available and theshape of the component. The vibration generator (62) in this embodimentis a piezoelectric vibrator (72) which is in the form of a block thatmay contain a single or a series of stacked transducers to producevibration. The receiving coil (86) may be located between the vibrationgenerator (62) and the case (20) to take advantage of the largest opencircular area. FIG. 10 illustrates the placement of three button cellbatteries (80) which comprise the power supply (78). The elements of thereceiver (92), the charging circuit (84) and the micro processor (96)may be integrated into printed circuit boards that occupy the remaininginterior (60) space.

FIG. 11 depicts the embodiment of the implant device (12) of FIGS. 8though 10 with a mount (28) in the form of a mesh (48). The mesh (48) inFIG. 11 is attached to the exterior (22) of the case (20) of the implantdevice (12) along an equatorial plane, which may have a seam or jointbetween complimentary sections of the case (20), but the invention isnot so limited. It is anticipated that a mount (28) in any form could beconnected to the exterior (22) of the case (20) at any point or evenformed as part of the case (20).

The embodiment illustrated in FIGS. 8 through 11 may be configured formounting the implant device (12), for example, on or near an organ orwithin relatively soft muscle tissue (4) or upon the deep fascia (5) ofstriated muscle tissue (4). It is anticipated that the entire exterior(22) surface area of the case (20) of the implant device (12) mayconstitute an engaging surface (24). In this embodiment, the tissue thatthe engaging surface (24) may engage with may be organ tissue, muscletissue (4) or deep fascia (5).

A third embodiment of the implant device (12) is illustrated in FIG. 12.In this embodiment the implant device (12) demonstrates some of the samecharacteristics as the embodiment illustrated in FIG. 5 but thestructure of the implant device (12) takes a different shape. Similar tothe disc shaped embodiment of FIG. 5, the embodiment of FIG. 12 includesmounts (28) in the form of flanges (30) with apertures (32) foraccepting an appropriate mounting element (98) such as, for example, ascrew (36), bolt (38), nail, brad, line (44), suture (50), staple (52),detent, ring and the like. The exterior (22) of the case (20) alsoincludes a groove (58) that is in the form of a depressed region locatedbetween ridges located at the proximal and distal ends of the implantdevice (12). The depressed region of the groove (58) may facilitate theuse of a band (54) or other mounting elements (98) such as, for example,a staple (52), suture (50), mesh (48), clamp (56) or a line (44) thatmay extend into and engage the groove (58) and connect with other nearbytissue.

FIG. 13 shows the engaging surface (24) of the embodiment of the implantdevice (12) depicted in FIG. 12. Similar to the embodiment depicted inFIG. 6, the engaging surface (24) is generally flat and includes boneengaging tines (26) that may or may not be used in conjunction with themounts (28).

FIG. 14 is an exploded view of the embodiment shown in FIGS. 12 and 13that illustrates elements located in the interior (60) of the implantdevice (12). In this and other embodiments, the receiving coil (86)forms an outer tube, in which some of the other interior (60) elementsreside. The vibration generator (62) in this embodiment is in the formof a solenoid (76) which may be moved by magnetic forces along asubstantially cylindrical access way formed by two electromagnetic coilswhich generate the magnetic forces that cause the solenoid (76) toproduce vibrations. The self-contained power supply (78) in thisembodiment is in the form of a battery (80) that conforms to theinterior (60) shape of the exterior (22) engaging surface (24). To takeadvantage of all of the available space the battery (80) in thisembodiment is a flat battery (82).

FIG. 15 shows another embodiment of an implant device (12) which has anexterior that is substantially cylindrical in shape. At each end of thecase (20) may be mounts (28) that may have a substantially conicalshape. An aperture (32) may be included in each mount (28). In FIG. 15,the proximal aperture (32) extends through the mount (28) in asubstantially straight and linear fashion while at the proximal end theaperture (32) extends through the mount (28) in a non-linear andgenerally curved manner. The characteristics of the aperture (32) in anyembodiment of the implant (12) may reflect the specific method ofmounting that is desired for or required by the particular placement ofthe implant device (12) within the patient (1). The mount (28) that isillustrated in FIG. 15 may comprise a material that would function as abuffer for the vibrations produced by the implant device (12).

As illustrated in FIG. 16, the distribution of elements in the interior(60) may be dictated by the shape of the exterior (22) of the case (20).In the embodiment depicted in FIGS. 15 through 17 the receiving coil(86) is configured with a tube like structure inside the interior (60)of the case (20). Positioned inside the receiving coil (86) may be thevibration generator (62), which is illustratively a motor (64), and maybe a cylindrical motor (66). The shaft or axle of the motor (64) may beattached to a flywheel (70) which has an eccentric mass. At the oppositeend of the interior (60) of the case (20) is the internal power supply(78) which is depicted in this embodiment as a battery (80) that mayhave a cylindrical shape. Between the power supply (78) and thevibration generator (62) may be a printed circuit board which maycontain a switch (90), a charging circuit (84), a receiver (92) and/or amicroprocessor (96).

FIG. 18 illustrates another embodiment of the implant device (12) inwhich the exterior (22) of the case (20) has a generally an ovoid shape.The mount (28) shown in FIG. 18 comprises a groove (58) that may beengaged by a band (54) functioning as a mounting element (98) that mayattach the implant device (12) to other mounting elements (98), such as,for example, a pair of clamps (56), a number of apertures (32) and aline (44) forming a loop (46). In this embodiment of the implant device(12), means for mounting are employed for the purpose of mounting theimplant device (12) between the spinous process (9) of two adjoiningvertebrae (8). For this positioning of the implant device (12), themounting structure includes a pair of connected clamps (56) which arespring biased and are shown clasping each of the spinous processes (9).Both clamps (56) include a group of tines (26) that engage and penetratethe bone tissue (6) of their respective spinous process (9). One of theclamps (56) utilizes the set of apertures (32) on the distal ends of theclamp (56) which are inter-threaded with a line (44) between theopposing jaws of the clamp (56). The line (44) completes a loop (46)with the jaws of the clamp (56) encircling the spinous process (9) ofone of the vertebrae (8). It is anticipated other combinations of mounts(28) and/or mounting elements (98) may also be utilized in this area, toachieve similar effects. The actual implant device (12) may be attachedto the clamp (56) by the band (54). The band (54) may be a part of, orconnected to, the clamp (56) which engages the groove (58) of theexterior (22) of the case (20) of the implant device (12). The band (54)in this embodiment includes a mechanism for tightening the band (54) toform a stable connection to the mounting means.

The embodiment depicted in FIGS. 19 and 20 includes structures suitablefor treating some more specific locations and conditions of a patient(1). For example, a patient (1) may suffer spinal trauma which producespain. The implant device (12) may be placed as close to the affectedarea of the body of the patient as possible to optimize the effect ofthe vibratory massage. In areas targeted for administration of vibratorymassage that are densely packed with muscle, ligament, tendon (7) andbone it has been determined that transmitting or distributing thevibratory massage through the targeted area of the vertebrae (8) hassignificant benefit. A relatively rigid structure for attaching theimplant device (12) to the vertebrae (8) is suitable for attaining sucha benefit. An ovoid shape for the exterior (22) of the case (12) may besuitable for fitting the space between the adjacent spinous process (9).The capability of the vertebrae (8) to function as a vibratorycommunication medium is enhanced by the use of a structure providing arigid mounting between the implant (12) and the vertebra, and a suitablemounting structure may employ a clamp (56). A double clamp (56) mountingmay have the added function or benefit of immobilizing the targetedvertebrae (8) to prevent further damage. The design of the mountingstructure employed may also take into consideration the eventuality thatthe implant device (12) may later be removed from or replaced in thepatient (1) while leaving the implanted mounting structure within thepatient (1).

The symptoms of the patient (1), the location of the implant device (12)in the patient, and/or prognoses of the patient may call forsignificantly different combinations and configurations of the implantdevice (12), including the shape of the exterior (22) of the case (20),the elements in the interior (60) of the implant device, the number ofthe implant devices (12) employed, and the type, number andconfiguration of the mounting elements (98) employed. The areas of thebody to be administered to, the range of anatomical topographies, andthe plurality of desired effects, all contribute to the wide variety ofcomponent forms and arrangements for the implant device (12) that may beutilized.

FIG. 21 illustrates a number of various configurations for the implantdevices (12) utilizing different mounting structures according to thepresent invention.

Implant device (12A) in FIG. 21 depicts an implant device similar to theembodiment depicted in FIGS. 5 through 7, which is illustratively shownattached to the bone tissue (6) of the calcaneus or heel bone. The case(20) of the implant device (12) includes an engaging surface (24) whichis contoured to substantially conform to the topography of the area ofthe calcaneus bone to which the implant device (12) is attached. Theengaging surface (24) includes a number of tines (26) to anchor theimplant device (12) solidly to the bone tissue (6) and to transmit thevibrations generated by the implant device (12) to tissue in contactwith the bone. The implant device (12) may be additionally secured tothe heel bone by a number of screws (36) which pass through an aperture(32) located in a flange (30) of a mount (28) on the implant device. Abuffer (34) may be included between the aperture (32) in the flange ofthe case (20) and the screws (36) to attenuate or isolate the screws(36) from vibrations of the case (20) that may loosen the screws (36) ordamage the bone tissue (6) if transmitted without some degree ofattenuation to the screws (36).

Implant device (12B) in FIG. 21 depicts an implant device similar to theembodiment depicted in FIGS. 12 through 14, which is illustrativelyshown attached to the bone tissue (6) of the fibula bone within thelower leg. The case (20) of the implant device (12) includes an engagingsurface (24) which is contoured to substantially conform to the curvedtopography of the area of the fibula bone to which the implant device(12) is mounted. FIGS. 22 and 24 are cross sectional examples of theengaging surface (24) employed on the implant device (12B). The curvedshape of the engaging surface (24) conforms to the curvature of theouter surface of the fibula where the implant device (12B) is attached.The engaging surface (24) includes a number of tines (26) to anchor theimplant device (12) solidly to the bone tissue (6) and to transmit thevibrations generated by the implant device (12) to tissue in contactwith the bone. In FIG. 22 the implant device (12B) may be additionallysecured to the fibula by a pair of screws (36) which each pass throughan aperture (32) of a flange (30) on the case (20) that forms a mount(28). A buffer (34) may be included between the aperture (32) and thescrews (36) to help isolate the screws (36) from vibrations of theimplant device (12B) that may loosen the screws (36) or damage the bonetissue (6) if transmitted without some degree of attenuation to thescrews (36).

Implant device (12C) in FIG. 21 shows an implant device similar to theembodiment depicted in FIGS. 5 through 7, which is illustratively shownattached to the bone tissue (6) of the ilium of the pelvic bone orflange of the hip bone. The case (20) of the implant device (12C)includes an engaging surface (24) which is contoured to substantiallyconform to the topography of the area of the pelvis bone to which theimplant device (12) is attached. FIG. 23 is a cross section of anexample of the mounting structure employed in the implant device (12C).The curved shape of the engaging surface (24) may be contoured tosubstantially conform to the curvature of the pelvic bone to which theimplant device (12C) is attached. The engaging surface (24) includes anumber of tines (26) to anchor the implant device (12) substantiallysolidly to the bone tissue (6) and to transmit the vibrations generatedby the implant device (12) to tissue in contact with the bone. Theimplant device (12C) may be additionally secured to the hip bone by anumber of threaded fasteners such as bolts (38) which pass through anaperture (32) of a flange (30) of the case (20) that form a mount (28).A buffer (34) may be included between the aperture (32) and the bolts(38) to attenuate or isolate the bolts (38) from vibrations. FIG. 23shows the bolts (38) passing through the bone tissue (6) and a plate(42) positioned on an opposite side of the bone tissue (6) and beingengaged by a nut (40) bearing against the plate (42). The nuts (40) mayhave a locking capability to resist the loosening that is often producedby exposure to vibration. Optionally, the use of the nuts (40) may beeliminated by attaching the bolt (38) directly to the plate (42), suchas by threading the aperture in the plate. The plate (42) may include anengaging surface (24) that is similar to the exterior (22) of the case(20) of the implant device (12) which may be contoured to conform to thetopology of the bone to which it contacts. The plate (42) may alsoinclude a number of tines (26) to anchor the implant device (12)substantially solidly to the bone tissue (6) and to help transmit thevibrations generated by the implant device (12) to tissue in contactwith the bone. Optionally, a buffer (34) may be included on the engagingsurface (24) of the plate (42) to isolate the bolts (38) from vibrationsof the implant device (12C).

Implant device (12D) in FIG. 21 shows an implant device similar to theembodiment depicted in FIGS. 12 through 14, which is illustrativelyshown attached to the bone tissue (6) of the femur bone within the upperleg. The case (20) of the implant device (12) includes an engagingsurface (24) which is contoured to substantially conform to the curvedtopography of the surface of the area of the femur to which the implantdevice (12) is attached. FIGS. 22 and 24 are cross sectional examples ofthe engaging surface (24) employed by the implant device (12D). Thecurved shape of the engaging surface (24) may thus substantially conformto the curvature of the femur where the implant device (12D) isattached. The engaging surface (24) includes a number of tines (26) toanchor the implant device (12) substantially solidly to the bone tissue(6) and to transmit the vibrations generated by the implant device (12)to tissue in contact with the bone. In FIG. 24, the implant device (12D)is shown secured to the femur by a band (54) which encompasses the outercircumference of a section of the femur. The band (54) may engage theimplant device (12) by nesting within a groove (58) formed on a portionof the exterior (22) of the case (20) of the implant device (12D). Theband (54) may comprise a relatively inflexible or even rigid materialsuch as metal, hard plastic, or inflexible fibers to provide asubstantially unyielding attachment or may comprise materials which haveflexible or even elastic qualities. The band (54) may also include amechanism for attaching one end of the band (54) to the other end of theband (54), in some examples in an adjustable manner. The attachmentmechanism may include, for example, a tension coupler, hinge pin,toothed grips, stitching, heat or sonic welds, an adhesive bond, abuckle, a hook and loop connector, and the like.

Implant device (12E) in FIG. 21 shows an implant device similar to theembodiment depicted in FIGS. 8 through 11, which is illustratively shownattached within the muscle tissue (4) of the quadriceps femoris withinthe upper leg. The implant device (12E) includes a mesh (48) mount (28)which is connected to the muscle tissue (4) of the quadriceps withsutures (50). Optionally, staples (52) may be used as a mounting element(98). Implant device (12) employing a mesh (48) for the mount (28) thatis implanted among the fibers within a muscle bundle may not require anyadditional mounting elements (98). The natural healing process of thebody of the patient may produce muscle tissue (4) that grows through theholes in the mesh (48) and may thus provide sufficient support to keepthe implant device (12) in place. It is anticipated that inimplementations where the implant device (12) is positioned within thefibers of a muscle bundle that a conforming engaging surface (24) (oroptionally no mounting structure at all) may be sufficient to keep theimplant device (12) in place.

Implant device (12F) in FIG. 21 shows an implant device similar to theembodiment depicted in FIGS. 8 through 11, which is illustratively shownattached to both the deep fascia (5) of a muscle bundle and bone tissue(6) using a mesh (48) as a mounting structure. An implant device (12)may be similarly attached to any type of bodily tissue, or combinationof types of bodily tissues such as, for example, organ tissue,cartilage, dermal tissue, tendons (7), ligaments, teeth, arteries,veins, glands, lymph nodes, nerve tissue, brain tissue, fat, superficialfascia, etc.

Implant device (12G) in FIG. 21 shows an implant device similar to theembodiment depicted in FIGS. 15 through 17, which includes a pair oflines (44) that are attached to the implant device (12G) through theapertures (32) mounted on either end of the case (20). The ends of thelines (44) located opposite the ends of the lines (44) that areconnected to the implant device (12G) may form loops (46) that encirclethe entire tendon (7) or a portion of the tendons (7) at either end ofthe muscle bundle. In this embodiment, the implant device (12) may belocated outside the deep fascia (5) on the outside of the muscle or maybe located amongst the muscle fibers inside the deep fascia (5).

Implant device (12H) of FIG. 21 shows an implant device (12) with agenerally flat shape which employs both meshes (48) and a line (44) andloop (46) to secure the implant device (12H) to the deep fascia (5) of amuscle bundle and to the tendon (7) respectively.

The mounting structure for implant device (121) shown in FIG. 21 issimilar to the mounting structure used for implant device (12G), butalso includes a third line (44) that is attached to apertures (32) atboth ends of the implant device (121) and encircles the muscle bundle ora portion thereof forming a loop (46). Any of the lines (44) may befurther anchored to the deep fascia (5) of the muscle tissue (4) throughthe use of supplementary mounting elements (98) such as, for example,sutures (50), staples (52), mesh (48), adhesives, and the like.

Implant device (12J) shown in FIG. 21 shows an implant device (12)similar to the embodiment depicted in FIGS. 5 through 7, which includesa plurality of lines (44) attached to apertures (32) in a flange (30) ofthe case (20) forming mounts (28).

Portions of the various lines (44) are shown connected to the deepfascia (5) through the use of, for example, sutures (50) and staples(52).

FIG. 25 illustrates various structures for mounting more than oneimplant device (12) utilizing mounting elements (98). Implant device(12K) and implant device (12L) employ a mounting structure similar tothose of implant device (12G) and implant device (12I) of FIG. 21, butare attached to each other in a tandem arrangement with a member (suchas a line (44)) connecting implant device (12K) and implant device (12L)through the apertures (32).

Implant device (12M) and implant device (12N) of FIG. 25 employ amounting structure that is similar to that of implant device (12B) ofFIG. 21 but share a single screw (36) that passes through one aperture(32) of each of the implant devices (12M & N).

Implant device (120) and implant device (12P) in FIG. 25 employ amounting structure similar to that of implant device (12E) and implantdevice (12F) of FIG. 21 but are connected to one another by a mesh (48).

Implant device (12Q) and implant device (12R) in FIG. 25 employ amounting structure similar to that of implant device (12A) in FIG. 21but also similar to implant device (12M) and implant device (12N), theseimplant devices share a single screw (36) that passes through oneaperture (32) of each of the implant device (12M) and implant device(12N).

Implant device (12Q) and implant device (12R) in FIG. 25 employ amounting structure similar to that of implant device (12D) of FIG. 21,but these implant devices share a single band (54) that engages thegrooves (58) in the exterior (22) of the case (20) of implant device(12Q) and implant device (12R).

It is anticipated that a plurality of implant devices (12) may beattached to a single plate (42) either directly or through a fastener orfasteners, and that a single clamp (56) may be utilized to anchormultiple implant devices (12).

Another aspect of the invention, involves a method of relieving pain orother conditions of a patient by imparting or applying a vibratorymassage to tissue of the body of the patient, and most suitably tissuewithin the body of the patient. The method may include providing orobtaining an implant device (12) with features or elements such as thosethat have been described in this specification. The method may alsoinclude identifying tissue within the body of the patient that issuitable or desirable for the application of vibratory massage, such as,for example, tissue that is a source of discomfort or has suffered aninjury. For the purposes of this description, the tissue to be treatedwill be referred to as the identified tissue. The condition or injury tothe tissue of the patient may or may not be the cause for a paincondition in the patient. In other situations, the condition of theidentified tissue may simply be of the type that is capable ofbenefiting from the application of vibratory massage.

The method may further include implanting the implant device (12) withinthe body of the patient. This aspect of the method may further includesurgically opening the body of the patient such as by creating anincision in the tissue of the body of the patient to a location withinthe body of the patient at which the implant device (12) is to belocated. This aspect may also include positioning the implant device(12) in the body of the patient in a manner such that the implant deviceis capable of transferring vibration by the implant device (12) to theidentified tissue of the body of the patient. This aspect may alsoinclude placing the implant device (12) in contact with the identifiedtissue, and possibly mounting the implant device (12) on the identifiedtissue. Optionally, this aspect of the method may include mounting theimplant device (12) on tissue (other than the identified tissue) thatcontacts the identified tissue, so that vibrations are transferredthrough the tissue to the identified tissue. In one illustrative anduseful aspect of the method, the implant device (12) is positionedbetween two spinal processes of adjacent vertebrae of the patient, andthe implant device is mounted to the spinal processes of those adjacentvertebrae. Another aspect of the method may be closing the opening inthe body of the patient so that the implant device is contained withinthe body of the patient, which thus would prevent or eliminate anyphysical connection from the implant device to any device exterior ofthe body of the patient.

The method may additionally include causing vibration of the implantdevice within the body of the patient after implantation to therebyvibrate the identified tissue, and may further include sendinginstructions to the implant device to instruct it to vibrate. The methodmay include adjusting a frequency of the vibration of the implantdevice, and may include adjusting an amplitude of the vibration of theimplant device. The method may include terminating the vibration of theimplant device, and may also include resuming the vibration of theimplant device after the vibration has been previously terminated.

In other embodiments of the invention, such as are illustratively shownin FIGS. 26 through 33, an implant device (100) has a case (102) withanother adaptation that facilitates the mounting of the device on thepatient, and also facilitates the transmission of the vibrations of thecase to the tissue. In these embodiments, contours on the exteriorsurface (104) of the case (102) help to secure and anchor the case onthe tissue of the body of the patient. These contours in the surface(104) may illustratively form a tissue engaging structure (106) thatfacilitate the mounting the device (100) on tissue. In more detail, thecase (102) forms at least a portion of an exterior of the implant device(100) and defines an interior of the implant device as described above.The exterior surface (104) of the case (102) may be is configured tosecure the case on a particular type of tissue of the body of thepatient. Illustratively, the tissue of the patient may be at least onebone of the patient, and in the illustrative embodiments the tissuecomprises a spinous process (2) of at least one vertebra 4 of the spineof the patient. The tissue may comprise the spinous processes (2, 3) oftwo adjacent vertebrae (4, 5). The case (102) may be elongated with alongitudinal axis A, and a first end (108) and a second end (110). Theexterior surface (104) of the case (102) may also have a generallycylindrical shape.

The tissue engaging structure (106) on the exterior surface (104) may beconfigured to secure the case on tissue of the body of the patient. Thetissue engaging structure (106) may include at least one helical ridge(112) formed on the exterior surface (104) of the case (102) andextending in a helical configuration about the circumference of thegenerally cylindrical exterior surface (104). The helical ridge (112)may extend from the second end (110) of the case (102) toward the firstend (108) of the case. The helical ridge (112) may form a screwthread-like element. Optionally, the helical ridge (112) may beconfigured to cut threads or thread-receiving grooves into the patient'stissue, such as the bone of a spinous process.

A first bearing structure (114) may be formed by or mounted on the case(102) and may form or provide a first bearing surface (116) for bearingagainst the tissue of the patient, such as the bone of the spinousprocess, to facilitate and enhance the transmission of the vibration tothe spinous processes. The first bearing structure (114) may be locatedtoward the first end (108) of the case (102). The first bearingstructure (114) may be integrally formed with the case (102), or may bemountable on the case by bonding on the case or rotation on the threads.The first bearing surface (114) may extend in a plane that is orientedsubstantially perpendicular to the longitudinal axis A of the case. Theridge (112) may extend from the second end (110) of the case toward andsubstantially to the first bearing surface (116). The first bearingstructure (114) may include a tool engaging structure (118) that isconfigured to be engaged by a tool. The tool engaging structure (118)comprises at least two flat surfaces (120, 122) on the first bearingstructure that may be located on substantially opposite sides of thefirst end (108) of the case. The tool engaging structure (118) mayinclude three pairs of opposite surfaces arranged in a hexagonalconfiguration in a manner similar to the hexagonal head of a fastener tofacilitate the ability of a took to engage opposite surfaces of the toolengaging structure in a confined surgical space regardless of theorientation of the structure (118). As illustrated in FIG. 32, one tool(150) which is suitable for engaging the opposite surfaces of the toolengaging structure (118) includes a pair of opposed faces (152, 154) forabutting the at least two flat surfaces (120, 122) of the tool engagingstructure.

A bearing member (124) may be mountable on the case (102), and may havea second bearing surface (126) for bearing against the bone tissue ofthe patient, such as the aforementioned spinous processes of theadjacent vertebrae, to facilitate the transmission of case vibration tothe tissue. The second bearing surface (126) may extend in a planeoriented substantially perpendicular to the longitudinal axis of thecase when the bearing member (124) is mounted on the case. The bearingmember (124) may be configured to be removable from the case once themember (124) is mounted on the case (102), although it should berecognized that the bearing member and case contour may be configured ina way that permits mounting of the bearing member on the case, but doesnot permit removal of the bearing member once it is mounted on the case.

Illustratively, the bearing member (124) may be configured to engage theridge (112) of the tissue engaging structure (106). The bearing member(124) may have an aperture (126) therein through which a portion of thecase (102) may be passed. The aperture (126) may be defined by anaperture surface (130) on the bearing member (124). The aperture surface(130) may be generally cylindrical in shape. The aperture surface (126)may include at least one helical groove (132) which may be complementaryto the helical ridge (112) of the exterior surface of the case (102)such that rotation of the bearing member (124) with respect to the casein a first rotational direction moves the bearing member onto and alongthe case in a first longitudinal direction, and conversely rotation ofthe bearing member with respect to case in a second rotational directionmoves the bearing member along the case in a second longitudinaldirection and off of the case.

The contouring of the exterior surface, such as the helical ridge (112),may function not only to engage the tissue to anchor the case (102) tothe tissue, but also to removably mount the bearing member (124) to thecase during implantation of the case. Rotation of the bearing member(124) on the helical ridge (112) of the case (102) causes the bearingmember to press the second bearing surface (126) against the tissue, andhelps press the tissue against the first bearing surface (116).

The embodiments of the device (100) may be utilized in a space betweenspinous processes and that may partially extend into the processes toenhance the securement of the device as well as enhance the transmissionof the vibration to the vertebrae of the spine. Further, the positioningof the case of the device (100) between the spinous processes mayfunction to help immobilize the spinous processes and the correspondingvertebrae with respect to each other, and may also put the vertebrae ina flexed condition. One or both of the spinous processes (2, 3) betweenwhich the case (102) is to be mounted may have a portion removed tofacilitate the mounting of the case therebetween.

In my copending patent application entitled “SURGICAL DRILL APPARATUS”,U.S. patent application Ser. No. 12/326,580, filed Dec. 2, 2008, whichis incorporated herein by reference in its entirety, a surgical drilldevice and a technique of forming a space between the spinous processesis disclosed that is suitable for receiving the case (102). The use ofthe drill apparatus (or other suitable device) may remove arcuate bites(6, 7) out of the respective spinous processes (2, 3) to form asubstantially circular or cylindrical space between the processes toreceive the case (102). Optionally, but not critically, the approximatediameter size of the space may be less than the diameter size of thecase (102). Illustratively, the case (102) may have a diameter size ofapproximately 1 cm to approximately 2 cm, and the diameter size of thespace formed between the spinous processes (2, 3) by the drill apparatusmay be approximately 2 mm smaller than the diameter size of the case.The length of the case may be approximately 3 cm to approximately 4 cm.In one illustrative embodiment, the case has a length of approximately 3cm and a diameter size of approximately 1 cm which is suitable forplacement between the spinous processes of adjacent vertebrae of thespine.

It should be recognized that the vibratory implant device of thedisclosure is useful for treating conditions other than pain as ananalgesic. For example, the vibration produced by the implant device maybe transmitted to various organs for the purpose of alleviatingconditions in those organs or causing reactions by the organs. Thevibrations may be administered in the manners described previously inthis disclosure, and may be activated for periods of time to providealleviate the condition being treated for those periods, or may besubstantially constant without interruption.

In one exemplary application, the vibration of the implant device may beutilized to suppress the appetite of the patient for the ultimatepurpose of causing or facilitating weight loss. The vibrations of theimplant device may produce waves in the stomach tissue of the stomachwall that stimulate nerve fibers, (such as, for example, gastricdistension mechanoreceptors) to help suppress appetite and cause asatiated feeling in the patient. Looking to FIGS. 34 through 37, onesuitable configuration (200) of the implant device is depicted in whichthe case (202) of the device (200) includes a passage (204) that extendsthough a portion of the exterior surface (206) of the case. The case(202) may be substantially cylindrical and may have ends that arerounded or semispherical, and the passage (204) may have openings (208,209) that are basically located on the same side of the case (see FIGS.34 and 35). The passage 204 is designed to receive a suture (210) orother securing member to hold or help hold the case (202) to the stomachS. As shown in FIGS. 36 and 37, a portion of the stomach S may bewrapped about the case (202) of the device (200) to thereby increase thearea of contact between the exterior surface of the case and theexterior surface of the stomach. A suture (210) or other element may beused to attach the case to the stomach S. The suture (210) may be passedthrough the openings (208, 209) and the passage (204) of the case (202),and the suture (210) may be threaded through the spaced portions (212,214) of the stomach wall to draw the portions of the stomach walltogether about the case. By this technique, the case (202) is secured tothe stomach S while the stomach is brought into more intimate and closecontact with the exterior of the case.

In another exemplary application of the implant device, the vibrationproduced by the device may be utilized to cause urination, or emptyingof the bladder through normal channels, to treat bladder dysfunction ora urinary tract obstruction as well as ultimately prevent or reduce theoccurrence of conditions such as bladder infection, diverticulumformation in the bladder, or bladder dilation when such dilation isundesirable, as well as other conditions of the bladder. The vibrationsproduced by the implant device (12) may stimulate the nerves thatcontrol the external sphincter and bladder functions to enhance theevacuation of the bladder. Looking to FIG. 38 of the drawings, theimplant device (12) is shown positioned on a surface of the exterior ofthe bladder B. The device (12) may be positioned on a superior surfaceof the bladder B, and may be positioned between the locations on thebladder B where the ureters are joined to the bladder, although otherpositions for the device may be employed. The application of vibrationto the bladder B may be periodic, or may be triggered by other factorssuch as detection that the bladder has filled with urine to apredetermined extent, as well as by patient activation.

In yet another exemplary application of the implant device, thevibration produced by the implant device may be employed to cause abowel movement by transmitting vibration to various areas of the colonor large intestine, to ultimately resolve fecal impaction orconstipation conditions, and a megacolon condition, as well as otherconditions of the colon or bowel. Looking to FIG. 39 of the drawings,two possible positions or locations for the implant device (12) areillustrated. These positions of the implant device (12) may be used inthe alternative, although two or more of the implant device (12) may bepositioned to act on different or similar positions on the colon C. Forexample, for the conditions such as fecal impaction or constipation,positioning of the device on or adjacent to the sigmoid colon C, andparticularly the mid-sigmoid colon, at or adjacent to the location ofthe device marked 12A, would be effective. As another example, for thecondition of megacolon, positioning of the device on or adjacent to thedescending colon, and particularly the mid-descending colon, at oradjacent to the location of the device marked 12B, would be effectiveparticularly as this is an area where innervation is absent. Thevibrations from the implant device stimulate nerve fibers in the wall ofthe colon to coordinate colonic wall movement and the advancement ofstool along the colon.

In another exemplary application of the implant device, the vibrationproduced by the implant device may be employed to treat or minimizesexual dysfunction in male and female patients, although it should berecognized that the device may be employed where no dysfunction ispresent. For example, when utilized to treat sexual dysfunction in afemale patient, the implant device (12) may be positioned internally inthe suprapubic region of the abdomen (see FIG. 40), where the vibrationsgenerated by the implant device may be transferred to the clitoral andvaginal nerve fibers to facilitate or cause a sensation of sexualpleasure. As another example, when used to treat sexual dysfunction in amale patient, the implant device may be positioned in the penis alongthe dorsal aspect region (see FIGS. 41A and 41B), where vibrationsstimulate the penile nerve fibers to facilitate and increase blood flowin the penis and a stronger erection. Further, the positioning of theimplant in the dorsal aspect region may allow vibrations from theimplant device (12) in the penis to be transmitted to the clitoralregion of the female partner during copulation. Although other positionswithin the penis may be employed, it is believed that the dorsal aspectportioning provides the greatest benefit to the patient.

It should be recognized that any manner disclosed herein for suitablysecuring the implant device to the organ to be affected, or a bodystructure adjacent or in communication with the organ to be affected,may be utilized, as well as other methods not set forth in thisdisclosure. Furthermore, the structure of the implant device (12) thatis employed, including the configuration of the case, may be anysuitable for securing the device and transmitting the vibration to thedesired organ or tissue. In some of the methods of utilizing the implantdevice, the device is positioned on or against the exterior surface orintegument of the organ to be affected, although it is possible thatpositions interior to the organ or tissue may be utilized.

It should be appreciated from the foregoing description and the manyvariations and options disclosed that, except when mutually exclusive,the features of the various embodiments described herein may be combinedwith features of other embodiments as desired while remaining within theintended scope of the disclosure.

It is to be understood that the above description is intended to beillustrative, and not restrictive. Many other embodiments andcombinations of elements will be apparent to those skilled in the artupon reviewing the above description and accompanying drawings. Thescope of the invention should, therefore, be determined with referenceto the appended claims, along with the full scope of equivalents towhich such claims are entitled.

What is claimed:
 1. A method, comprising: placing an implant device nearan exterior surface of a colon, the implant device configured to produceand communicate a vibration to colon tissue, the implant deviceincluding a case forming at least a portion of an exterior of theimplant device and defining an interior of the implant device, avibration generator mounted on the case and configured to vibrate the atleast the portion of the exterior of the implant device, a powerreceiver comprising a receiving coil and configured to receiveelectrical energy from a remote source, the power receiver beingdisposed adjacent to the vibration generator, and a tissue engagingstructure located on the exterior surface of the case and configured toengage the colon tissue; securing the implant device to an exteriorsurface of the colon; and activating the vibration generator of theimplant device to cause the implant device to vibrate against theexterior surface of the colon, wherein a vibration of the implant deviceagainst the exterior surface of the colon is configured to stimulate anerve to induce a bowel movement.
 2. The method of claim 1, whereinplacing the implant device includes positioning the case against asurface of a sigmoid portion of the colon.
 3. The method of claim 1,wherein securing the implant device includes suturing the case to a wallof the sigmoid portion of the colon.
 4. The method of claim 1, whereinplacing the implant device includes positioning the case against asurface of a descending portion of the colon.
 5. The method of claim 1,wherein securing the implant device includes suturing the case to a wallof a descending portion of the colon.
 6. The method of claim 1, whereinsecuring the implant device includes passing a suture through a passagein the case and through a wall of the colon, the passage extending froman opening on a side of the case, through a portion of the case, toanother opening on the side of the case.
 7. The method of claim 1,wherein the nerve induces movement of a wall of the colon to advancestool through the colon.
 8. The method of claim 1, wherein the vibrationgenerator comprises an electrical motor.
 9. The method of claim 1,wherein the vibration generator comprises a piezoelectric vibrator. 10.The method of claim 1, wherein the activating the vibration generator isperformed periodically to advance stool through the colon.
 11. Themethod of claim 1, wherein the activating the vibration generator isinitiated manually using a remote control device.
 12. The method ofclaim 1, wherein the case is formed of a biocompatible material.
 13. Themethod of claim 1, wherein the implant device further comprises a powersupply mounted on the case and configured to supply power to thevibration generator.
 14. The method of claim 1, wherein the activatingthe vibration generator includes receiving using a signal receivermounted on the case a signal from a remote source.